BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1171176 · Received September 22, 2008

    Report

    Report Number
    2134265-2008-02762
    Event Type
    Injury
    Date Received
    September 22, 2008
    Date of Event
    May 12, 2008
    Report Date
    September 1, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING RECORDS FOR THIS BATCH HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. AS NO DEVICE WAS RECEIVED FOR ANALYSIS IT IS NOT POSSIBLE TO PERFORM ANY INSPECTIONS ON THE DEVICE. THEREFORE IT IS NOT POSSIBLE TO DETERMINE IF ANY ISSUES EXISTED WITH THE ACTUAL UNIT THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT. THE ROOT CAUSE OF THIS EVENT IS ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    POST MARKET SURVEILLANCE STUDY. IT WAS REPORTED THAT 222 DAYS FOLLOWING A CORONARY ARTERY DRUG ELUTING STENTING PROCEDURE, THE PATIENT DEVELOPED IN-STENT RESTENOSIS. THE INDEX PROCEDURE TREATED THE OSTIAL, DE NOVO, 56% STENOSED, MODERATELY TORTUOUS, 3.38X30.4MM LESION OF THE PROXIMAL RCA (RIGHT CORONARY ARTERY). TREATMENT CONSISTED OF DIRECT STENTING USING A 3.5X32MM TAXUS EXPRESS2 DRUG ELUTING STENT AND POST DILATION RESULTING IN 6% RESIDUAL STENOSIS CONFIRMED BY IVUS (INTRAVASCULAR ULTRASOUND). THE STENT WAS WELL POSITIONED AND WELL APPOSED. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY ON ASA AND PANALDINE. THE PATIENT RETURNED FOR A FOLLOW UP EVALUATION 222 DAYS FOLLOWING THE INDEX PROCEDURE. ANGINA WAS NOT PRESENT, BUT 55% RESTENOSIS OF THE DISTAL PORTION OF THE TAXUS EXPRESS2 DRUG ELUTING STENT WAS CONFIRMED. TREATMENT CONSISTED OF PLACEMENT OF ANOTHER UNKNOWN SIZE TAXUS EXPRESS2 DRUG ELUTING STENT IN THE TARGET LESION RESULTING IN 18% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. THE INVESTIGATOR ASSESSED THIS EVENT AS POSSIBLY RELATED TO THE STUDY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ - STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC CORPORATION 3.5X32MM 9560970

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R